Conventional colostomies involve a surgical procedure in which the intestine is severed and an end of the intestine is exteriorized through an incision in the abdominal wall of a patient. The anastomosis of the intestine to the peritoneum and skin of the abdominal wall is such as to provide a passage for intestinally-contained fecal matter to pass to the outside of the patient's body. The nipple-like termination of this passage is called the "stoma".
The foregoing operation results in a loss of continence for the patient and he or she must typically wear a polymer pouch on the outside of the body or a reconstructed pouch of surgically enlarged intestinal tissue on the inside of the body in order to collect the fecal matter passing through the abdominal stoma, which additionally necessitates surgical relocation of the intestine from its natural anal opening to an artificial abdominal stoma site. In order to avoid such incontinence, several types of occlusion devices have been proposed for closing off the stoma in order that a patient need not be burdened with a pouch. No such device has had either a true, sphincter-like mechanical action or allowed the intestinal transcutaneous elimination passage to remain in its natural location.
Most such closure devices require a complicated surgical procedure, involving an invasion into the intestine itself. Further, any such closure device located on the abdominal wall or immediately beneath the abdominal wall of the area of the stoma is "unnatural" in its specific location.
Aside from proper control of the distal intestine by closure devices, there is further a need for the use of such devices in controlling other elimination passages such as the urethra for post-prostectomy patients, having undergone the trans-urethral resection procedure.
In my copending patent application Ser. No. 370,099 filed Apr. 20, 1982 and entitled Intestinal Control Valve, now U.S. Pat. No. 4,401,107 there is described an intestinal control valve which can be surgically implanted without invading the intestine itself. Further, the valve can be located at the end of the intestine in a normal or "natural" position of the sphincter muscle. While the valve is designed such that it will close off the distal intestine of a patient in a manner analogous to the operation of a normal sphincter muscle, it requires an electric drive motor incorporated in the valve itself operable from a remote location by appropriate electrical means. As a consequence, the profile is somewhat elongated for this valve. Further, it is necessary to monitor the battery life for supplying electrical power.
In my later filed copending patent application Ser. No. 435,761, there is provided an improved closure device in the form of a synthetic sphincter which again can be readily surgically implanted without ischemia and erosion of the elimination passage. This closure is so designed that there is no need for an electrical drive motor in the closure device itself. Rather a flexible cable is utilized to actuate the same from a remote location. The closure itself can thus be made with a very short axial length or low profile and is thus useful even for smaller diametric elimination passages such as the urethra. Nevertheless, the actuating component for the cable involves the use of a small battery powered electic motor, and thus this device as in my original case has a requirement for periodically monitoring the battery life.